DOJ Issues New FCA Guidance on Cooperation Credit
May 8, 2019 | Geoffrey R. Kaiser | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation
On May 7, the U.S. Department of Justice (DOJ) introduced important new guidance for government attorneys explaining how DOJ will award credit to defendants who cooperate during a False Claims Act (FCA) investigation through voluntary self-disclosure, remediation (e.g., disciplining wrongdoers or others who failed in oversight, or implementing or improving an effective compliance program) and/or …
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Diagnostic Imaging Provider Pays $3 Million to Settle Data Breach
May 7, 2019 | Eric D. Fader | Cybersecurity | Electronic Health Records | HIPAA | Litigation
Touchstone Medical Imaging has agreed to pay $3 million to settle HIPAA violations after an unsecured computer server exposed the medical records of 300,000 patients on Google in 2014. The U.S. Department of Health and Human Services (HHS) announced the settlement on May 6. Touchstone, based in Franklin, Tennessee, provides diagnostic imaging services in Nebraska, …
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NYS Reaffirms Support for No-Fault Fraud Law
May 6, 2019 | Rivkin Rounds Staff | Fraud and Abuse | Legislation and Public Policy | Litigation | Private Insurers
The New York State Department of Financial Services has filed an amicus brief with the New York Court of Appeals reaffirming its position that a medical professional corporation “is not eligible for reimbursement” under the state’s No-Fault Law “if the provider fails to meet any applicable New York State or local licensing requirement necessary to …
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Stem-Cell Clinics Under Fire
April 11, 2019 | Cassandra Rivais DiNova | FDA | Fraud and Abuse | Litigation
On April 3, the U.S. Food and Drug Administration (FDA) sent warning letters to about 20 stem-cell clinics notifying them that their activities appear to require FDA approval. The letters, similar in form to this one, cited guidance materials that clinics can use as resources in becoming compliant with FDA requirements. Stem-cell therapy involves removing …
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EHR Exposé Shakes Up Industry
March 19, 2019 | Eric D. Fader | Electronic Health Records | False Claims Act | Fraud and Abuse | Hospitals | Legislation and Public Policy | Litigation | Medicare and Medicaid
A three-month joint investigation of electronic health records (EHR) systems has culminated in a release of a March 18 article in Kaiser Health News (KHN) and Fortune Magazine, “Death By 1,000 Clicks: Where Electronic Health Records Went Wrong.” The lengthy, meticulously sourced article calls EHR systems “an unholy mess.” KHN and Fortune have made the …
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Embryo Destruction Lawsuits Open New Legal Frontier
February 21, 2019 | Katherine A. Heptig | Cassandra Rivais DiNova | Litigation
As of January 2019, following a months-long break in the cases due to judicial transition, at least 70 lawsuits arising from the accidental destruction of human embryos and eggs were pending in Ohio state courts. The cases highlight the complex questions surrounding the legal status of embryos and, by consequence, theories of liability for the …
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Anti-Assignment Clause Bars Doctor’s Reimbursement Claim
February 20, 2019 | Rivkin Rounds Staff | Litigation | Private Insurers
Rivkin Radler’s Employee Benefit Plan Review included a summary of a case in which the U.S. Court of Appeals for the Eleventh Circuit held that an anti-assignment provision in a group health benefit plan barred direct reimbursement to an Atlanta dermatologist. The patient had executed an Assignment of Benefits in favor of the physician, a …
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FDA Issues Warning Letter on Unapproved Breast Implant Device
February 19, 2019 | Steven Shapiro | FDA | Litigation | Medical Devices and Wearables
Last week, the U.S. Food and Drug Administration (FDA) announced that it issued a warning letter to Mark Berman, M.D., a Beverly Hills, Calif., cosmetic surgeon, for illegally marketing an unapproved implantable device. Dr. Berman claims that the “Pocket Protector” can prevent and treat capsular contracture (tightening of scar tissue), a complication of breast implants. …
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HIPAA Still Applies to Patients’ Online Reviews of Providers
February 15, 2019 | Cassandra Rivais DiNova | Electronic Health Records | HIPAA | Litigation
In an era of online dialogue, healthcare providers still need to remain alert regarding their obligations under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). As tempting as it may be to respond to patients’ criticisms and praise online, healthcare providers, as “covered entities” under HIPAA, should think twice before clicking “post.” It’s …
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EHR Vendor to Pay $57 Million to Settle FCA Case
February 11, 2019 | Geoffrey R. Kaiser | Electronic Health Records | False Claims Act | Fraud and Abuse | Litigation | Medicare and Medicaid
On February 6, the U.S. Department of Justice announced that Greenway Health LLC, a Florida-based developer of electronic health records (EHR) software, will pay $57.25 million as part of a False Claims Act settlement. The United States had alleged that Greenway misrepresented the capabilities of its software product, called “Prime Suite,” causing healthcare providers to submit …
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